10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- EBI Patient Care, Inc.
- Reason for Recall:
- Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Product Codes/Lot Numbers:
Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2119-2017
Related Recalls
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
EBI Patient Care
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.